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( 2.9 / 273 )Silicone gel implants
Thomas Cronin and Frank Gerow, two Houston, Texas, plastic surgeons, developed the first silicone breast prosthesis with the Dow Corning Corporation in 1961. The first woman was implanted in 1962. Silicone implants are generally described in terms of five generations which segregate common characteristics of manufacturing techniques.
* First generation
The Cronin-Gerow implants were made of a silicone rubber envelope (or sac), filled with a thick, viscous silicone gel with a Dacron patch on the posterior shell.[19] They were firm and had an anatomic "teardrop" shape.
* Second generation
In response to surgeons' requests for softer and more lifelike implants, breast implants were redesigned in the 1970s with thinner gel and thinner shells. These implants had a greater tendency to rupture and leak, or "bleed" silicone through the implant shell, and complications such as capsular contracture were quite common. It was predominantly implants of this generation that were involved in the class action-lawsuits against Dow-Corning and other manufacturers in the early 1990s.
Another development in the 1970s was a polyurethane foam coating on the implant shell which was effective in diminishing capsular contracture by causing an inflammatory reaction that discouraged formation of fibrous tissue around the capsule. These implants were later briefly discontinued due to concern of potential carcinogenic breakdown products from the polyurethane.[20] A review of the risk for cancer from TDA by the FDA later concluded that the risk was so small so as not to justify recomending explantation of the devices from individual patients. Polyurethane implants are still used in Europe and South America, but no manufacturer has sought FDA approval for sale in the United States.[21] Second-generation implants also included various "double lumen" designs. These implants were essentially a silicone implant inside a saline implant. The double lumen was an attempt to provide the cosmetic benefits of gel in the inside lumen, while the outside lumen contained saline and its volume could be adjusted after placement. The failure rate of these implants is higher than for single lumen implants due to their more complex design. The contemporary versions of these devices ("Becker Implants") are used primarily for breast reconstruction.
* Third & Fourth generation
Third & fourth generation implants, from the mid 1980s, represented sequential advances in manufacturing principles with elastomer-coated shells to decrease gel bleed, and are filled with thicker, more cohesive gel. These implants are sold under restricted conditions in the U.S. and Canada, and are widely used in other countries. The increased cohesion of the gel filler reduces potential leakage of the gel compared to earlier devices. A variety of both round and tapered anatomic shapes are available. Anatomic shaped implants are uniformly textured to reduce rotation, while round devices are available in smooth or textured surfaces.
* Fifth generation
Evaluation of "gummy bear" or solid, high-cohesive, form-stable implants is in preliminary stages in the United States but these implants have been used since the mid 1990s in other countries. The semi-solid gel in these type of implants significantly reduces the possibility of silicone migration. Studies of these devices have shown significant potential improvements in safety and efficacy over the older implants with low rates of capsular contracture and rupture.
http://en.wikipedia.org/wiki/Breast_implant
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( 2.9 / 236 )You may be considering breast implant surgery to increase the size of your breasts. This is
referred to as breast augmentation. Or you may need revision of a previous breast
augmentation, which is called revision-augmentation. Allergan has prepared this information to help you better understand the breast implant procedure and assist you in making an informed decision about breast augmentation or revision-augmentation surgery. It will help to answer some of the questions you may have about the surgery and aboutbreast implants in general. It will also provide you with specific information about the risks and benefits of INAMED Silicone-Filled Breast Implants.
This information cannot and should not replace discussing your surgery with your plastic surgeon. Your decision whether or not to get breast implants should be based on realistic expectations of the outcome. There is no guarantee that your results will match those of other
women.
Your results will depend on many individual factors, such as your overall health (including age), chest structure, breast/nipple shape and position, skin texture, healing capabilities (which may be slowed by radiation and chemotherapy treatment, smoking, alcohol,
and various medications), tendency to bleed, prior breast surgery, surgical team’s skill and experience, type of surgical procedure, and type and size of implant. Make sure you speak with
your surgeon about your expectations of the results, as well as what you can expect regarding the length of the surgery, your recovery, and any risks and potential complications of the surgery. Ask questions.
As part of your decision, both you and your surgeon will be required to sign Allergan’s consent
to surgery form that confirms your understanding of what you have read. This Allergan consent
document will be provided to you by your surgeon.
You should wait at least 1-2 weeks after reviewing and considering this information before deciding whether to have primary breast augmentation surgery. In the case of a revision-
augmentation however, your surgeon may find it medically necessary to perform surgery sooner.
http://www.fda.gov/cdrh/pdf2/P020056d.pdf
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( 3 / 199 )by Linda Bren
At the same time that Mattel's redesigned, smaller-busted Barbie doll was making its way onto the shelves of this nation's stores in 1998, a record number of the nation's women opted for a kind of surgery that would give them larger busts.
Breast augmentation has become the second most commonly performed cosmetic surgical procedure after liposuction, according to the American Society of Plastic Surgeons. In 1998 alone, more than 130,000 women in the United States underwent the procedure. This number grew to 191,000 in 1999--a 51 percent increase over the previous year and nearly a 500 percent increase since 1992.
breast augmentation surgeries increase from 1992 to 1999[D]
Prior to 1992, two types of breast implants were available. Both had an outer silicone shell filled with either silicone gel or saline (sterile salt water). But since 1992, most of the breast implants have been of the saline variety because in that year, the Food and Drug Administration restricted the use of silicone gel-filled implants. This restriction was spurred by the concern that silicone gel leaking into the body could be harmful, and by the inability of the manufacturers to provide adequate safety data on their implants. FDA's decision eight years ago means that silicone-gel implants can only be used in controlled clinical studies for the purposes of reconstruction after mastectomy, correction of congenital deformities, or replacement of ruptured silicone-gel implants that were used for augmentation.
Saline-filled implants are believed to be safer than silicone because rupture or leakage will only release salt water--not silicone gel--into the body. Consequently, FDA has allowed these implants to remain on the market without evidence of safety until this year.
That evidence of safety was presented by McGhan Medical Corporation and Mentor Corporation, both of Santa Barbara, Calif., to an FDA advisory panel on March 1-3. On May 10, following the panel's recommendation, FDA approved saline-filled breast implants made by these two manufacturers. The products are approved for breast augmentation in women 18 years or older and for breast reconstruction in women of all ages.
http://www.fda.gov/fdac/features/2000/400_implant.html
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( 3 / 185 )Some surgeons feel that silicone implants have a more natural look and feel than saline implants because silicone gel has a texture that is similar to breast tissue. Saline implants have some advantages over silicone implants. Silicone implant ruptures are harder to detect. When saline implants rupture, they deflate and the results are seen almost immediately. When silicone implants rupture, the breast often looks and feels the same because the silicone gel may leak into surrounding areas of the breast without a visible difference. Replacing a ruptured silicone gel implant is more difficult than repairing a saline implant. Silicone implants also have a higher rate of capsular contracture and a higher deflation rate.
Saline Implants
Saline implants have a silicone rubber shell that is inflated to the desired size with sterile saline. Most implants have a valve that is sealable by the surgeon.
There are two types of saline-filled implants. One type is a fixed volume implant, which is filled with the entire volume of saline at implantation. Another type is an adjustable volume implant, which is filled intraoperatively and has the potential for further postoperative adjustment. FDA Approval
On May 10, 2000, the FDA granted approval of saline-filled breast implants manufactured by Mentor Corporation and McGhan Medical. To date, all other manufacturers' saline-filled breast implants are considered investigational.
Silicone Implants
Silicone implants have a silicone rubber shell that is filled with a fixed amount of silicone gel. Each implant has a patch that covers the manufacturing port of the implant.
Silicone implants vary in shell surface (smooth/textured), shape, profile, volume, shell thickness, and number of shell lumens. Most silicone gel-filled implants are not adjustable.
In the early 1990's it was reported that silicone breast implants were responsible for connective tissue diseases in some women. After a comprehensive evaluation of the evidence for the Association of Silicon Breast Implants with human health conditions, the Institute of Medicine concluded in June that there is "no definitive evidence linking breast implants to cancer, neurological diseases, neurological problems or other systemic diseases." However, silicone implants are still not available to the general public in the United States. They are still widely used in Europe and may be available again in the US.
Silicone gel-filled breast implants are available for select cases: women seeking breast reconstruction or revision of an existing breast implant, women who have had breast cancer surgery, a severe injury to the breast, a birth defect that affects the breast, or a medical condition causing a severe breast abnormality.
The U.S. Department of Health and Human Services states:
"For some years controversy has existed over silicone implants used for breast augmentation or replacement after mastectomy. Adverse effects from their use have been widely reported in the popular press, with conflicting information often appearing in the medical literature. This controversy and the attendant publicity led the Food and Drug Administration (FDA) first to ban any use of these implants and then to permit limited use, mainly as replacement after mastectomy.
"Silicone is used not only in breast implants but also in implants located literally throughout every part of the body. It has been used: to construct heart valves and other cardiovascular prostheses; to fashion catheters which are used for purposes ranging from drug delivery to cardiac monitoring; in dentistry; in the gastrointestinal tract; as a facilitator for nerve regeneration; in ophthalmology; in the ear, nose, throat, and respiratory tract; as a prosthesis or ingredient in prostheses for many parts of the skeletal system; as a tissue expander; as a cosmetic agent for treatment of scars and wrinkles; in the urogenital tract, including penile prostheses; and in many other applications."
http://www.smartbreastaugmentation.com/implants.html
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( 3 / 189 )Some surgeons feel that silicone implants have a more natural look and feel than saline implants because silicone gel has a texture that is similar to breast tissue. Saline implants have some advantages over silicone implants. Silicone implant ruptures are harder to detect. When saline implants rupture, they deflate and the results are seen almost immediately. When silicone implants rupture, the breast often looks and feels the same because the silicone gel may leak into surrounding areas of the breast without a visible difference. Replacing a ruptured silicone gel implant is more difficult than repairing a saline implant. Silicone implants also have a higher rate of capsular contracture and a higher deflation rate.
Saline Implants
Saline implants have a silicone rubber shell that is inflated to the desired size with sterile saline. Most implants have a valve that is sealable by the surgeon.
There are two types of saline-filled implants. One type is a fixed volume implant, which is filled with the entire volume of saline at implantation. Another type is an adjustable volume implant, which is filled intraoperatively and has the potential for further postoperative adjustment. FDA Approval
On May 10, 2000, the FDA granted approval of saline-filled breast implants manufactured by Mentor Corporation and McGhan Medical. To date, all other manufacturers' saline-filled breast implants are considered investigational.
Silicone Implants
Silicone implants have a silicone rubber shell that is filled with a fixed amount of silicone gel. Each implant has a patch that covers the manufacturing port of the implant.
Silicone implants vary in shell surface (smooth/textured), shape, profile, volume, shell thickness, and number of shell lumens. Most silicone gel-filled implants are not adjustable.
In the early 1990's it was reported that silicone breast implants were responsible for connective tissue diseases in some women. After a comprehensive evaluation of the evidence for the Association of Silicon Breast Implants with human health conditions, the Institute of Medicine concluded in June that there is "no definitive evidence linking breast implants to cancer, neurological diseases, neurological problems or other systemic diseases." However, silicone implants are still not available to the general public in the United States. They are still widely used in Europe and may be available again in the US.
Silicone gel-filled breast implants are available for select cases: women seeking breast reconstruction or revision of an existing breast implant, women who have had breast cancer surgery, a severe injury to the breast, a birth defect that affects the breast, or a medical condition causing a severe breast abnormality.
The U.S. Department of Health and Human Services states:
"For some years controversy has existed over silicone implants used for breast augmentation or replacement after mastectomy. Adverse effects from their use have been widely reported in the popular press, with conflicting information often appearing in the medical literature. This controversy and the attendant publicity led the Food and Drug Administration (FDA) first to ban any use of these implants and then to permit limited use, mainly as replacement after mastectomy.
"Silicone is used not only in breast implants but also in implants located literally throughout every part of the body. It has been used: to construct heart valves and other cardiovascular prostheses; to fashion catheters which are used for purposes ranging from drug delivery to cardiac monitoring; in dentistry; in the gastrointestinal tract; as a facilitator for nerve regeneration; in ophthalmology; in the ear, nose, throat, and respiratory tract; as a prosthesis or ingredient in prostheses for many parts of the skeletal system; as a tissue expander; as a cosmetic agent for treatment of scars and wrinkles; in the urogenital tract, including penile prostheses; and in many other applications."
Source:http://www.nlm.nih.gov/pubs/cbm/silicone.html
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( 3 / 137 )Silica is the most common substance on earth. It is a constituent of most rocks. Beach sand is almost pure crystalline silica, as is quartz, which in its purest form is a clear or rosy-colored gemstone, found in geodes, or, if less pure, may be found as amethyst, agate, flint, or "petrified wood." The molecular formula of silica is SiO2, silicon dioxide. Silicon dioxide is a three-dimensional network of silicon (Si) atoms linked by oxygen (O) atoms in a 2:1 ratio; each silicon atom is linked to four oxygen atoms, and each oxygen to two silicon atoms.
A crystalline substance is one whose atoms form a regular pattern over large distances. This regularity is usually measured by the diffraction of x-rays. The constructive and destructive interference of x-ray waveforms causes the x-ray beam to be redirected into a reproducible pattern that can be detected by photographic film. The characteristics of this pattern allow calculation of the precise atomic spacing. This regularity is also a key to the hardness and strength of most crystalline substances.
Although human exposure to crystalline silica is extensive and generally to no ill effect, tissue (especially lung) exposure to particulate silica or silica dust has well defined toxic, inflammatory outcomes (American Thoracic Society, 1997). Silica is also found in less toxic, amorphous forms (Warheit et al., 1995). Amorphous materials, in which the atoms are not found in regular arrays even though the atomic ratios are the same, do not give crystalline patterns. Amorphous forms of silica include a vitreous
http://books.nap.edu/openbook.php?recor ... mp;page=39
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